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The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.

Japan Plans Breakthrough Designation for Devices

At the recent International Medical Device Regulators Forum (IMDRF) meeting in Moscow, Japanese regulators said they plan to introduce mechanisms to allow for rapid access to needed devices and in vitro diagnostics.

Japan recently adopted its “Sakigake” pathway for breakthrough biologics that allows for provisional approval based on limited clinical data, and it wants to introduce a similar pathway for devices. The new device pathway would need to be approved by legislation.

The proposal would allow for rapid practical use of needed devices “based on the premise of ensuring safety,” representatives of Japan’s Pharmaceuticals and Medical Devices Agency said. The system would use patient registries or similar electronic tracking to boost postmarket surveillance.